TELMISARTAN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ)

Available from:

medsource pharmaceuticals

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Telmisartan is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacol

Product summary:

Telmisartan Tablets, USP are supplied as below: 20 mg, white to off-white color, round, flat, beveled edge, uncoated tablets debossed with ‘L202’ on one side and plain on other side. NDC 62332-087-30 bottle of 30 units NDC 62332-087-91 bottle of 1000 units NDC 62332-087-10 blister of 100 units as 10 x 10 cards 40 mg, white to off-white color, oval shape, biconvex, uncoated tablets debossed with ‘L203’ on one side and plain on other side. NDC 62332-088-30 bottle of 30 units NDC 62332-088-91 bottle of 1000 units NDC 62332-088-10 blister of 100 units as 10 x 10 cards 80 mg, white to off-white color, oval shape, biconvex, uncoated tablets debossed with ‘L204’ on one side and plain on other side. NDC 62332-089-30 bottle of 30 units NDC 62332-089-91 bottle of 1000 units NDC 62332-089-10 blister of 100 units as 10 x 10 cards Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Tablets should not be removed from blisters or bottles until immediately before administration.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TELMISARTAN- TELMISARTAN TABLET
MEDSOURCE PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TELMISARTAN TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TELMISARTAN TABLETS.
TELMISARTAN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNINGS._
WHEN PREGNANCY IS DETECTED, DISCONTINUE TELMISARTAN AS SOON AS
POSSIBLE (5.1, 8.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND EVEN DEATH TO THE
DEVELOPING FETUS (5.1, 8.1)
INDICATIONS AND USAGE
Telmisartanis an angiotensin II receptor blocker (ARB) indicated for:
(1)
Treatment of hypertension to lower blood pressure. Lowering blood
pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and myocardial
infarctions(1.1)
DOSAGE AND ADMINISTRATION
•May be administered with or without food (2.1) (2)
INDICATION
STARTING DOSE
DOSE RANGE
Hypertenstion (2.1) 40 mg once daily 40 to 80 mg once daily
DOSAGE FORMS AND STRENGTHS
Tablets: 20 mg, 40 mg, 80 mg (3)
CONTRAINDICATIONS
Known hypersensitivity (e.g., anaphylaxis or angioedema)to telmisartan
or any other component of this product (4)
Do not co-administer aliskiren with telmisartan in patients with
diabetes (4)
(4)
WARNINGS AND PRECAUTIONS
Avoid fetal or neonatal exposure (5.1)
Hypotension: Correct any volume or salt depletion before initiating
therapy. Observe for signs and symptoms of
hypotension (5.2)
Monitor carefully in patients with impaired hepatic (5.4) or renal
function (5.5)
Avoid concomitant use of an ACE inhibitor and angiotensin receptor
blocker (5.6)
ADVERSE REACTIONS
Hypertension: The most common adverse events (≥1%) reported in
hypertension trials are back pain, sinusitis, and
diarrhea (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ALEMBIC PHARMACEUTICALS
LIMITED AT 1-866-210-9797
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
NSAIDs: Increas